Right Ventricular DysfunctionNCT04694378
Relationship Between Strain and Stroke Volume in Cardiac Surgery
An observational study of Right Ventricular Dysfunction and Stroke Volume Index, run by Tufts Medical Center at 1 site in United States.
Trial summary
Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction, Stroke Volume Index, Longitudinal Heart Strain
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients older that 18 years old.
Who may be able to join
- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.
Who cannot join
- Patients with contraindication to Swan-Ganz catheter placement,
- Pre-existing atrial arrhythmias,
- Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
- Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery
Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.
Aim:
Read more
Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery
Hypothesis:
- Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
- Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.
- Keywords
- Echocardiography, Coronary artery bypass graft, Thermodilution
- Medical subject headings
- Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of right ventricular function during CABG assessed by right heart strain (%)
Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length.
Measured: during CABG surgery
Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)
Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)
Measured: during CABG surgery
Secondary outcomes (1)
Change in cardiac output measured with Swan-Ganz during CABG
Cardiac output (L/min) measured with the thermodilution technique
Measured: during CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694378
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2020
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04694378
- Acronym / sponsor ID
- 1
- Keywords
- Echocardiography, Coronary artery bypass graft, Thermodilution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.
Aim:
Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery
Hypothesis:
- Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
- Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients older that 18 years old.
Key inclusion criteria (1 listed)
- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.
Key exclusion criteria (4 listed)
- Patients with contraindication to Swan-Ganz catheter placement,
- Pre-existing atrial arrhythmias,
- Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
- Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of right ventricular function during CABG assessed by right heart strain (%)
Time frame: during CABG surgery
Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length.
Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)
Time frame: during CABG surgery
Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)
1 secondary outcome
Change in cardiac output measured with Swan-Ganz during CABG
Time frame: during CABG surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction and Stroke Volume Index, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of right ventricular function during CABG assessed by right heart strain (%) (time frame: during CABG surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.